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Primary Objective:
The primary objective of this study is to compare whether the addition of one year of everolimus (10 mg daily) to standard adjuvant endocrine therapy improves invasive disease-free survival (IDFS) in patients with high-risk, hormone-receptor (HR) positive and HER2-negative breast cancer.
Secondary Objectives:
a. To compare whether the addition of one year of everolimus to standard adjuvant
endocrine therapy improves overall survival (OS) and distant recurrence-free
survival (DRFS) in this patient population.
b. To evaluate the safety, toxicities and tolerability of one year of everolimus in combination with standard adjuvant endocrine therapy and compare it with standard adjuvant endocrine therapy plus placebo in this patient population.
c. To determine whether the benefit of one year of everolimus use in addition to
standard adjuvant endocrine therapy varies by recurrence score (RS), nodal status, or other commonly used prognostic factors.
d. To evaluate adherence to 1-year treatment of everolimus in comparison to placebo in addition to standard adjuvant endocrine therapy in this patient population.
e. To collect specimens in order to evaluate biomarkers of therapeutic efficacy.
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